Safety & Training

Experiment Hazard Class 7.5 – Human Tissue/Materials

Applicability

This hazard classification applies to all experiments involving biohazards requiring the use of human tissue/materials. Other hazard classifications and their associated hazard controls may also apply to experiments in this hazard class. Human tissue/materials must also be evaluated for their biosafety level and as such will have to go through the process for that particular Biosafety Level.

IMPORTANT NOTE: For non-Argonne employees, all experiment protocols involving human tissue are required to be either reviewed or declared exempt from review by their home institution's Institutional Review Board (IRB). Documentation of the review should be filed in the ESAF system and with the APS BioSafety Officer (BSO) (Nena Moonier 630-252-8504, nmoonier@aps.anl.gov) For Argonne employees who will be involved in an experiment dealing with human materials an IRB application to the Uof C IRB must be submitted. The UofC IRB will then determine if a full review is needed or declare it exempt from review. Argonne employees may obtain the Uof C application by contacting Gail Van Gorp(630-252-3689, gvangorp@anl.gov) . Documentation must also be filed in the ESAF system as well.

In addition at an IRB review, human tissues may require approval from the Argonne Institutional Biosafety Committe: Please see note below.

*Chemically fixed non-neuronal human tissue is still required to be reviewed by the IRB and the APS BSO but not the Argonne Instutional Biosafety Committee (IBC) as the samples will be devoid of any infectious agents.

*All non fixed human tissues must go through a full review by the Argonne IBC. Please see below for the application process.

An ANL-955 form should be filled out to do a risk assessment on the biological material. Please contact APS Biosafety Officer Nena Moonier (630-252-8504 nmoonier@aps.anl.gov) for the ANL-955 Biological Materials Assessment form if you can not access the link or any of the links mentioned below. Please submit the ANL-955 form to the APS Biosfaety Officer (BSO). From there, the Argonne Institutional Biosafety Committee (IBC) Chair and or APS BSO will determine if the materials in the experiment consitute a biological hazard and or regulated by the federal goverment and requires a permit to transport and process. If the material is determined to be non hazardous nor non regulated then the PI will be informed in writting that a full IBC review is not needed and the materials can be handled at BSL1.

*Chemically fixed non-neuronal human tissue may still be required to be reviewed by the Institutional Review Board (IRB).

***ALL Central nervous system human tissue regardless of fixation process will, in additon to being reviewed by the IRB, will also need to be reviewed by the ANL Intitutional Biosafety Committee (IBC). Please fill out a registration form ANL-812 for your samples through the IBC website.

Experiments involving non fixed human tissue/materials are considered high risk.

Experiments involving non fixed human tissue/materials are considered high risk.

Engineered Controls – As determined in the safety review of the experiment..

Procedural Controls – An SOP describing the handling of the samples will be needed for samples classified as BSL2 or higher.

Design Reviews and Equipment Inspections –All experiment protocols involving human tissue (even if there is no biohazard) are required to be either reviewed or declared exempt from review by Institutional Review Board. Please contact Nena Moonier (630-252-8504, nmoonier@aps.anl.gov) for details. The User must provide a copy of the review by the Institutional Review Board of their home institution. A letter of exempt status and proof of anonymity is required for the samples. The home Institutional Review Board letter and associated sample documents may be attached to the "Description" page of the ESAF.

In addition non fixed human tissue will require Argonne IBC approval before work may begin.

Signs and Labeling – The work area must be posted for the appropriate hazard. Signs may be obtained from the AES ES&H Coordinator or the APS Biosafety Officer.

Personal Protective Equipment – As specified in the written SOP for the experiment.

Experiment Authorization

Unless otherwise noted in the approved experiment safety plan, the PSC Deputy Associate Laboratory Director of Operations delegates the authority to authorize an experiment in this hazard class to the Argonne Institutional Review Board, a member of the APS Experiment Safety Review Board and resident Beamline Management personnel appearing in the Director of the AES's list of personnel having the authority to authorize experiments.

Hazard Control Verification

The PSC Deputy Associate Laboratory Director of Operations delegates responsibility for verifying that required controls are in place to personnel delegated the authority to perform this task to APS ES&H Coordinator, the experiment On-site Spokesperson, and Beamline Management personnel having experiment safety responsibilities.